74 Participants Needed

SAPIEN M3 System for Mitral Regurgitation

(SAPIEN M3 EFS Trial)

Recruiting at 8 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Edwards Lifesciences
Must be taking: Heart failure medication
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial will test the safety and effectiveness of the SAPIEN M3 System in patients with severe mitral regurgitation. The device is designed to help the heart valve close properly, preventing blood from flowing backward. The study aims to gather information for future research on this treatment. The SAPIEN M3 System is part of the SAPIEN family of heart valves, which have been used in various applications including aortic and mitral valve replacements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be stable on heart failure medication for at least 2 weeks before the procedure.

What data supports the effectiveness of the SAPIEN M3 System treatment for Mitral Regurgitation?

The Edwards Sapien 3 valve, a component of the SAPIEN M3 System, has been optimized to reduce complications in aortic valve treatments, suggesting potential effectiveness in similar heart valve conditions. Additionally, the PASCAL system, another Edwards Lifesciences device for mitral regurgitation, has shown positive outcomes in reducing mitral valve issues, indicating that similar technologies from the same company may be effective.12345

Is the SAPIEN M3 System generally safe for humans?

The Edwards SAPIEN transcatheter heart valve, a related device, has been evaluated for safety in high-risk patients with aortic stenosis and was found to have benefits that outweigh the risks, according to an FDA panel. Additionally, early trials for similar devices in different heart conditions have been conducted to assess safety.16789

How is the SAPIEN M3 System treatment for mitral regurgitation different from other treatments?

The SAPIEN M3 System is unique because it uses a transcatheter approach, meaning it is delivered through a small tube inserted into a blood vessel, which is less invasive than traditional surgery. This system is adapted from the SAPIEN 3 valve, which is known for its precise implantation and reduced risk of leakage around the valve, making it a novel option for treating mitral regurgitation.1231011

Eligibility Criteria

This trial is for adults with severe mitral valve regurgitation who are at high risk for heart surgery, stable on heart failure meds, and not pregnant. They must understand the study and consent to it. Excluded are those with other valve issues, mechanical aortic valves, history of certain cardiovascular events or procedures within specified time frames, participation in another study, refusal of blood products, specific cardiac conditions that could interfere with treatment effectiveness or safety.

Inclusion Criteria

I am 18 years old or older.
You have heart problems that affect your ability to do physical activities.
The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
See 3 more

Exclusion Criteria

Your heart's shape would make it difficult to put in the device or valve correctly.
I have kidney problems or am on dialysis.
I have liver disease or abnormal liver test results.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Subjects will undergo transcatheter mitral valve replacement using the SAPIEN M3 System

Procedure day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including reduction in mitral regurgitation

30 days
1 visit (in-person)

Treatment Details

Interventions

  • Edwards SAPIEN M3 System
Trial OverviewThe Edwards SAPIEN M3 System is being tested to see if it's safe and works well for treating severe symptomatic mitral regurgitation (MR). The trial will help design future studies by collecting initial data on this new medical device's performance.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TMVRExperimental Treatment1 Intervention
Subjects will undergo transcatheter mitral valve replacement

Find a Clinic Near You

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton profile image

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian profile image

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

In a study of 235 patients with severe aortic stenosis, the use of the Edwards Sapien 3 valve for transcatheter aortic valve implantation (TAVI) resulted in no cases of moderate or severe residual aortic regurgitation, indicating high device success.
The procedure, performed without general anesthesia, showed low rates of major vascular complications (3.0%), mortality (2.6%), and stroke (2.1%) within 30 days, demonstrating its safety and efficacy across different valve sizes.
Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience.Wรถhrle, J., Gonska, B., Rodewald, C., et al.[2019]
The PASCAL system effectively treated severe mitral regurgitation (MR) in 92 patients, achieving a high overall success rate of 97.8%, with significant improvements in MR severity and patient quality of life at follow-up.
Patients experienced notable reductions in proBNP levels and pulmonary capillary wedge pressure, indicating improved heart function, with a low major adverse event rate of only 1.2% cardiovascular death at 30 days.
Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort.Barth, S., Shalla, A., Kikec, J., et al.[2022]
The Edwards SAPIEN transcatheter heart valve (THV) is considered noninferior to traditional surgical aortic valve replacement for high-risk operable patients, based on the high-risk arm of the PARTNER trial.
Despite some concerns about safety and trial misconduct, the FDA panel unanimously agreed that the benefits of the Edwards SAPIEN THV outweigh the risks, leading to its approval for use in this patient population.
Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients.Barbash, IM., Dvir, D., Waksman, R.[2013]

References

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. [2019]
Functional and hemodynamic results after transcatheter mitral valve leaflet repair with the PASCAL device depending on etiology in a real-world cohort. [2022]
PASCAL mitral valve repair system versus MitraClip: comparison of transcatheter edge-to-edge strategies in complex primary mitral regurgitation. [2022]
Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device. [2021]
One-Year Outcomes According to Mitral Regurgitation Etiology Following Transcatheter Edge-to-Edge Repair With the PASCAL System: Results From a Multicenter Registry. [2023]
Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. [2013]
Repositionable Versus Balloon-Expandable Devices for Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis. [2018]
Percutaneous implantation of the Edwards SAPIEN transcatheter heart valve for conduit failure in the pulmonary position: early phase 1 results from an international multicenter clinical trial. [2022]
A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Multicenter evaluation of a next-generation balloon-expandable transcatheter aortic valve. [2022]
Edwards Sapien 3 Valve for Mitral Replacement in a Child After Melody Valve Endocarditis. [2017]